About this trial
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80
Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels
Willing and able to give consent
Disqualifiers
Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)
Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)
Known allergy to bupivacaine, clonidine or similar local anesthetics
Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)
Trial design
Parallel
Treatments tested in this trial
Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine
DrugBupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
normal saline
Drugnormal saline in 30cc syringes administered using ESPB technique
Treatment groups
Trial outcomes
Primary outcomes
Inpatient opioid consumption
Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)
Secondary outcomes
Post-discharge opioid consumption
Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients
Postoperative opioid prescriptions filled
• Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website
Length of hospital stay
Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria
Postoperative Urinary Retention (POUR)
Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
John O'Toole
Lead sponsor
Rush University Medical Center
Sponsor institution